Namandjé N. Bumpus Principal Deputy Commissioner at U.S. Food And Drug Administration (fda) | Official website
Namandjé N. Bumpus Principal Deputy Commissioner at U.S. Food And Drug Administration (fda) | Official website
This is an increase over the number of companies cited in the previous quarter.
The citations in the county include:
- Procedures for training and identifying training needs have not been established.
- Procedures to prevent contamination of equipment or product by substances that may have an adverse effect on product quality have not been adequately established.
- Equipment calibrations, inspections, checks and maintenance activities have not been documented.
The company cited should take a voluntary action to correct its managing operations.
The FDA routinely inspects facilities across the nation to determine if the workplace and their products are compliant with FDA-regulated laws and regulations implemented to improve overall public health. Inspection results are then disclosed publicly.
The FDA is a government agency that is primarily responsible for monitoring the production and distribution of human and animal drugs, biological products, medical supplies and tobacco products for safety quality, according to its website.
| Company Name | Area of Business | Inspection Date | Issue Cited |
|---|---|---|---|
| Professional Contract Sterilization, Inc. | Devices | 02/16/2024 | Training - Lack of or inadequate procedures |
| Professional Contract Sterilization, Inc. | Devices | 02/16/2024 | Contamination control, Lack of or inadequate procedures |
| Professional Contract Sterilization, Inc. | Devices | 02/16/2024 | Equipment control activity documentation |
| Professional Contract Sterilization, Inc. | Devices | 02/16/2024 | Lack of or inadequate process validation |
| Professional Contract Sterilization, Inc. | Devices | 02/16/2024 | Documentation |
| Professional Contract Sterilization, Inc. | Devices | 02/16/2024 | Documentation |
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